Duchenne or Becker Muscular DystrophyNCT06186310
Effectiveness of Aquatic Therapy in Children With Duchenne and Becker Muscular Dystrophy
A study testing Aquatic Therapy Group and Conventional Physical Therapy Group in people with Duchenne or Becker Muscular Dystrophy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Duchenne or Becker Muscular Dystrophy
- What is being tested?
- Aquatic Therapy Group and Conventional Physical Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Duchenne Muscular Dystrophy or Becker Muscular Dystrophy by a neurologist
- Between the ages of 5-18, with ongoing ambulation
- Co-operating with the physiotherapist's practices
Who cannot join
- Those who will not be able to perform the evaluation parameters
- Have a serious systemic disease that may interfere with exercise
- Injury and/or surgery in the last 6 months
- Receive gene therapy
- In the presence of contraindications to aquatic therapy such as excessive fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wound, acute systemic disease, epilepsy, tracheotomy, permanent drain, immunodeficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, Gaziosmanpaşa, 34255
About this study
Official title: Effectiveness of Aquatic Therapy on Balance and Functionality in Children With Duchenne and Becker Muscular Dystrophy
The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.
Read the detailed description
Duchenne and Becker muscular dystrophy is the most common type of muscular dystrophy in childhood caused by a mutation of the DMD gene. Progressive muscle weakness is the main symptom, as muscle fiber degeneration is the primary pathological process.
Weakness selectively affects the proximal before the distal limb muscles and the lower before the upper limbs. The affected child therefore has difficulty running, jumping, and walking up steps.
Although there is currently no treatment method that eliminates the disease, exercise practices significantly improve the quality of life of children.
There are not enough studies in the literature evaluating whether the addition of aquatic therapy to conventional physical therapy helps to improve balance skills, functionality and quality of life in children with muscular dystrophy.
The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.
Our study will include children aged 5-18 years and complete a 10 -m walk without assistance/support who are diagnosed with Duchenne or Becker muscular dystrophy by a neurologist and followed up in the Muscular Diseases Unit of Gaziosmanpaşa Training and Research Hospital In follow-ups, patients who are planned to receive aquatic therapy will be listed according to their application dates.
In addition to the exercises home programme, patients at the top of the list will receive aquatic treatment 3 days a week for a total of 5 weeks with a physiotherapist.
Patients at the bottom of the list will form the control group and will receive home programme exercise while waiting in line for aquatic therapy After 5 weeks, the initial assessments will be repeated and recorded
- Conditions
- Duchenne or Becker Muscular Dystrophy
- Being tested
- Aquatic Therapy Group, Conventional Physical Therapy Group
- Keywords
- Aquatic Exercise Therapy, Muscular Dystrophy, Life Quality, Functional Status, Balance Control
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Therapy GroupOther
After the initial evaluations, patients will be given aquatic exercises including personalized strengthening, balance and breathing exercises accompanied by a physiotherapist 3 days a week for total 5 weeks. At the same time, the exercises taught as a home program will be asked to be repeated every day for 5 weeks.
Conventional Physical Therapy GroupOther
After the initial evaluations, patients in the control group will be taught passive, active, actively assisted or resistant upper and lower extremity exercises as a home program, appropriate to each patient's functional level and muscle strength. Subjects will be asked to perform the exercises every day for 5 weeks, not exceeding an average of 45 minutes, 5 to 10 repetitions of each exercise, depending on fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Therapy Group | Active comparator | in addition to the home programme exercises, aquatic exercises will be performed with a physiotherapist Receives: Other: Aquatic Therapy Group |
| Conventional Physical Therapy Group | Active comparator | Personalized exercises in the form of a home program will be demonstrated by the physiotherapist Receives: Other: Conventional Physical Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items: sitting to standing,standing to sitting,transfers,standing unsupported,sitting unsupported,standing with eyes closed,standing with feet together,standing with one foot in front,standing on one foot,turning 360 degrees,turning to look behind,retrieving object from floor,placing alternate foot on stool,reaching forward with outstretched arm. That are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: five weeks
Secondary outcomes (2)
Timed Performance Tests (walking 10 m, climbing 4 steps and descending 4 steps)
It will be used to evaluate the functional performance of children against time.
Time to climb a 4-step staircase: They will be asked to climb a 4-step stair platform in the same way they climb in daily life
Descending a 4-step ladder: They will be asked to descend a 4-step ladder platform in the same way they descend in daily life.
Time to walk a distance of 10 meters: Children are asked to walk a predetermined distance of 10 meters at the same pace they walk in their daily lives.Results will be recorded.
Measured: five weeks
The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module (PedsQL-3.0
The PedsQL 3.0 Neuromuscular Module scale was prepared in child self-report and parent report formats for children aged 5-18 years.The scale consists of a total of 25 items under 3 categories: symptoms related to neuromuscular disease, communication, and family resources.Items are scored on a Likert scale from 0 (never a problem) to 4 (always a problem).Higher scores on the module indicate better health-related quality of life
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start5 Nov 2023
- Primary completion23 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne or Becker Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a conventional physical therapy control group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ceyda Ulu, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ceyda Ulu, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186310
- Sponsor's protocol ID
- GaziosmanpasaTREH-FTR-CU-01
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmaz CU, Karabulut SS, Forestier FBE, Yalcinkaya EY. Effectiveness of aquatic therapy on balance and functionality in children with Duchenne and Becker muscular dystrophy : a prospective controlled pilot study. Dev Neurorehabil. 2025 Nov;28(8):296-303. doi: 10.1080/17518423.2026.2624412. Epub 2026 Jan 31.
PubMed 41620441
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aquatic Therapy on Balance and Functionality in Children With Duchenne and Becker Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06186310
- Acronym / sponsor ID
- GaziosmanpasaTREH-FTR-CU-01
- Conditions
- Duchenne or Becker Muscular Dystrophy
- Keywords
- Aquatic Exercise Therapy, Muscular Dystrophy, Life Quality, Functional Status, Balance Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.
Detailed description
Duchenne and Becker muscular dystrophy is the most common type of muscular dystrophy in childhood caused by a mutation of the DMD gene. Progressive muscle weakness is the main symptom, as muscle fiber degeneration is the primary pathological process.
Weakness selectively affects the proximal before the distal limb muscles and the lower before the upper limbs. The affected child therefore has difficulty running, jumping, and walking up steps.
Although there is currently no treatment method that eliminates the disease, exercise practices significantly improve the quality of life of children.
There are not enough studies in the literature evaluating whether the addition of aquatic therapy to conventional physical therapy helps to improve balance skills, functionality and quality of life in children with muscular dystrophy.
The purpose of this study is ; to evaluate the effects of aquatic therapy applied in addition to conventional physical therapy on balance, functionality and quality of life in children with Duchenne and Becker muscular dystrophy.
Our study will include children aged 5-18 years and complete a 10 -m walk without assistance/support who are diagnosed with Duchenne or Becker muscular dystrophy by a neurologist and followed up in the Muscular Diseases Unit of Gaziosmanpaşa Training and Research Hospital In follow-ups, patients who are planned to receive aquatic therapy will be listed according to their application dates.
In addition to the exercises home programme, patients at the top of the list will receive aquatic treatment 3 days a week for a total of 5 weeks with a physiotherapist.
Patients at the bottom of the list will form the control group and will receive home programme exercise while waiting in line for aquatic therapy After 5 weeks, the initial assessments will be repeated and recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with a conventional physical therapy control group
| Arm | Type | Receives |
|---|---|---|
| Aquatic Therapy Group | Active comparator | Other: Aquatic Therapy Groupin addition to the home programme exercises, aquatic exercises will be performed with a physiotherapist |
| Conventional Physical Therapy Group | Active comparator | Other: Conventional Physical Therapy GroupPersonalized exercises in the form of a home program will be demonstrated by the physiotherapist |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with Duchenne Muscular Dystrophy or Becker Muscular Dystrophy by a neurologist
- Between the ages of 5-18, with ongoing ambulation
- Co-operating with the physiotherapist's practices
Key exclusion criteria (5 listed)
- Those who will not be able to perform the evaluation parameters
- Have a serious systemic disease that may interfere with exercise
- Injury and/or surgery in the last 6 months
- Receive gene therapy
- In the presence of contraindications to aquatic therapy such as excessive fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wound, acute systemic disease, epilepsy, tracheotomy, permanent drain, immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Therapy GroupAfter the initial evaluations, patients will be given aquatic exercises including personalized strengthening, balance and breathing exercises accompanied by a physiotherapist 3 days a week for total 5 weeks. At the same time, the exercises taught as a home program will be asked to be repeated every day for 5 weeks. | Other | Aquatic Therapy Group |
| Conventional Physical Therapy GroupAfter the initial evaluations, patients in the control group will be taught passive, active, actively assisted or resistant upper and lower extremity exercises as a home program, appropriate to each patient's functional level and muscle strength. Subjects will be asked to perform the exercises every day for 5 weeks, not exceeding an average of 45 minutes, 5 to 10 repetitions of each exercise, depending on fatigue. | Other | Conventional Physical Therapy Group |
Primary outcome
Pediatric Berg Balance Scale
Time frame: five weeks
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items: sitting to standing,standing to sitting,transfers,standing unsupported,sitting unsupported,standing with eyes closed,standing with feet together,standing with one foot in front,standing on one foot,turning 360 degrees,turning to look behind,retrieving object from floor,placing alternate foot on stool,reaching forward with outstretched arm. That are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
2 secondary outcomes
Timed Performance Tests (walking 10 m, climbing 4 steps and descending 4 steps)
Time frame: five weeks
The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module (PedsQL-3.0
Time frame: five weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 41620441Yilmaz CU, Karabulut SS, Forestier FBE, Yalcinkaya EY. Effectiveness of aquatic therapy on balance and functionality in children with Duchenne and Becker muscular dystrophy : a prospective controlled pilot study. Dev Neurorehabil. 2025 Nov;28(8):296-303. doi: 10.1080/17518423.2026.2624412. Epub 2026 Jan 31.
- Individual participant dataSharing planned: No
Related trials for Duchenne or Becker Muscular Dystrophy
Enrolling by invitationObservational study
A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practice
Duchenne Muscular Dystrophy
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Active NBS Study: Decentralised Monitoring Motor Development in Children With Duchenne Muscular Dystrophy or Spinal Muscular Atrophy Identified by Newborn Screening
Spinal Muscular Atrophy (SMA), Duchenne Muscular Dystrophy (DMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceyda Ulu principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Therapy Group and Conventional Physical Therapy Group in people with Duchenne or Becker Muscular Dystrophy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Berg Balance Scale (time frame: five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.